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Early Diagnosis of PROstate CANcer for Black Men (PROCAN-B+)

2026年5月26日 更新者:Floor Christie-de Jong、University of Sunderland

Encouraging Early Diagnosis of PROstate CANcer for Black Men (the PROCAN-B+ Study): A Mixed-Methods, Two-Arm, Multi-Centre Randomised Controlled Trial of a Co-Produced, Peer-Led Intervention

PROCAN-B+ is a mixed-methods, two-arm, multi-centre randomised controlled trial evaluating a co-designed, peer-led intervention to encourage informed help-seeking and engagement with prostate cancer health checks and Prostate Specific Antigen (PSA) testing among Black men aged 45 years and over with no history of prostate cancer.

The study will recruit 300 participants across three UK sites: North East England including Leeds, Scotland, and London. Following eligibility screening and baseline data collection, participants will be individually randomised in a 1:1 ratio to either the intervention or wait-list control arm by an independent clinical trials unit. Participants allocated to the intervention arm will attend a two-hour co-designed community-based workshop shortly after randomisation, while participants allocated to the control arm will be invited to attend the workshop following the 6-month follow-up period. Due to the nature of the intervention, participants and researchers will not be blinded to allocation.

The intervention was co-designed in partnership with Black men and includes peer-led discussions on barriers to early diagnosis of prostate cancer, health education delivered by a Black GP, activities aimed at supporting effective communication with healthcare professionals, and video testimonials from prostate cancer survivors, women, and religious leaders.

Primary outcomes include self-reported discussions with GPs relating to prostate cancer risk, self-reported PSA testing, and GP-recorded PSA testing where participant consent is provided. Secondary outcomes include knowledge of prostate cancer, attitudes towards prostate cancer health checks and PSA testing, and help-seeking behaviours. Data will be collected at baseline, 3-month, and 6-month follow-up.

A qualitative process evaluation involving participants, peer facilitators, and professionals will explore experiences and acceptability of the intervention and inform future implementation and scale-up.

研究概览

详细说明

Black men have approximately twice the risk of developing prostate cancer compared with non-Black men and are more likely to experience poorer prostate cancer outcomes. Despite this increased risk, barriers including lack of awareness of prostate cancer risk, discomfort discussing sensitive health issues, and negative experiences with healthcare may contribute to delays in healp-seeking and early diagnosis.

To address these barriers, we worked with thirteen Black men to co-design a peer-led, community-centred intervention aimed at encouraging help-seeking and engagement with prostate cancer health checks and PSA testing. The intervention consist of a two-hour workshop including peer-led discussions on barriers to early diagnosis of prostate cancer, health education delivered by a Black GP, activities to support effective communication with healthcare providers, and video messages from prostate cancer survivors, women and religious leaders. The workshop also included a social component with music and food.

The intervention was piloted with 62 Black men in 2023-2024. Participants completed surveys before and after the intervention assessing changes in knowledge, attitudes and intentions relating to prostate cancer health checks and PSA testing. Findings suggested improved knowledge, attitudes and intentions. However, the sample size was small and robust effectiveness evaluation with a larger sample is now needed.

The PROCAN-B+ study is a two-arm multi-centre randomised controlled trial (RCT) with an embedded qualitative process evaluation. We aim to recruit 300 Black men aged 45 and over from three sites (100 per site): North East England and North Yorkshire, London and Scotland. Following eligibility screening and baseline data collection, participants will be individually randomised in a 1:1 ratio to intervention or wait-list control groups by an independent clinical trials unit. Intervention participants will receive the intervention workshops shortly after being recruited; while participants allocated to the wait-list control arm will be invited to attend the workshop following the 6-month follow-up period. Due to the nature of the intervention, participants and researchers will not be blinded to allocation.

Intervention workshop delivery will be supported by community members (n=15) who will be trained on workshop facilitation to become peer facilitators.

To assess effectiveness, participants will be asked to complete baseline questionnaires assessing knowledge of prostate cancer, attitudes towards prostate cancer health checks and PSA testing, and self-reported PSA testing. Follow-up questionnaires will be completed post intervention and at 3-month and 6-month follow-up. If participants provide consent, details of their general practitioners (GP) practice will be collected to enable verification of GP-recorded PSA testing at 6-month follow-up. Questionnaires will be administered online, using Qualtrics, or in paper format.

The qualitative process evaluation will involve focus groups and interviews with participants, peer facilitators and professionals to explore experiences and acceptability of the intervention and recommendations for improvement for future implementation and scale-up.

研究类型

介入性

注册 (估计的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Black men aged 45 years or over, living in North East England, North Yorkshire, London or Scotland

Exclusion Criteria:

  • Men from other ethnicities
  • Black men aged less than 45 years
  • Black men with previous prostate cancer diagnosis

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention
Participants in this arm will attend a two-hour community workshop designed to encourage informed help-seeking and engagement with prostate cancer health checks and PSA testing.
The intervention was co-designed in partnership with 13 Black men to address barriers and facilitators to early diagnosis of prostate cancer among Black men. The workshop includes multiple components, including peer-led discussions on barriers to early diagnosis, health education delivered by a Black GP, activities aimed at supporting effective communication with GPs and reception staff, and video testimonials from prostate cancer survivors, women, and religious leaders.
其他:Control
Participants in this arm will be placed on a waiting list and will be invited to attend the workshop after the 6-month follow-up period.
Participants in the control group will be placed on a waitlist to receive the intervention after six months

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Self-reported GP attendance to discuss prostate cancer health
大体时间:Baseline, 3 months, 6 months
Participants will be asked whether they discussed their risk of prostate cancer with their GPs and whether they requested a PSA test
Baseline, 3 months, 6 months
Self-reported PSA test
大体时间:Baseline, 3 months, 6 months
Participants will be asked if they had undergone a PSA test prior to the study and whether they underwent PSA testing following the intervention.
Baseline, 3 months, 6 months
GP recorded PSA tests
大体时间:6 months
If participants consent, they will be asked to provide details of their GP practice to verify whether they underwent or requested PSA testing following the intervention. Letters will be sent to each GP practice to confirm whether participants had requested or undergone PSA testing.
6 months

次要结果测量

结果测量
措施说明
大体时间
Knowledge of prostate cancer
大体时间:Baseline, 3 months, 6 months
Participants will be asked to complete questions adapted from Weinrich et al's (2004) knowledge of Prostate Cancer questionnaire
Baseline, 3 months, 6 months
Attitudes to prostate cancer
大体时间:Baseline, 3 months, 6 months
Thomas Jefferson University Prostate Cancer Screening survey will be used to assess attitudes towards prostate cancer screening
Baseline, 3 months, 6 months
Help-seeking behaviours
大体时间:Baseline, 3 months, 6 months
Help seeking behaviours related to prostate cancer will be assessed using items adapted from the Cancer Awareness Measure Plus (2024) questions.
Baseline, 3 months, 6 months

其他结果措施

结果测量
措施说明
大体时间
Perspectives on the intervention's content and delivery
大体时间:6 months
Participants, peer facilitators and professionals will be asked to take part in a qualitative process evaluation to explore their perspectives on the acceptability of the intervention content and delivery, and recommendations for future implementation.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Floor Christie-de Jong、University of Sunderland

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年8月31日

研究完成 (估计的)

2028年8月31日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Following study completion and publication of the main study findings, anonymised and de-identified data will be available from the principal investigator upon reasonable request and in accordance with ethical and data protection requirements.

IPD 共享时间框架

We will aim to publish the study protocol in the first year of the study. Findings will be published following study completion.

IPD 共享访问标准

Following study completion and publication of the main study findings, anonymised and de-identified data will be available from the principal investigator upon reasonable request and in accordance with ethical and data protection requirements.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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